Inhaled Colistin to Prevent Pediatric Ventilator-associated Pneumonia
- Conditions
- Ventilator Associated Pneumonia
- Interventions
- Drug: 0.9% Saline
- Registration Number
- NCT06488794
- Lead Sponsor
- University Hospital Fattouma Bourguiba
- Brief Summary
The goal of this clinical trial is to learn if nebulized colistin can prevent pneumonia in ventilated children. The main question it aims to answer is:
• Does nebulized colistin lower the number of times participants develop ventilation associated pneumonia? Researchers will compare nebulized colistin to a placebo (a look-alike substance that contains no drug) to see if nebulized colistin works to prevent ventilation associated pneumonia in children.
Participants will:
* Take nebulized Colistin or a placebo twice a day for 3 days.
* Will be followed to check for pneumonia occurrence while they are on mechanical ventilation.
- Detailed Description
The aim of the study is to evaluate the benefit of a 3-day course of inhaled colistin among children undergoing invasive mechanical ventilation for more than 2 days on the occurrence of ventilator-associated pneumonia.
A double-blind, multicenter randomized controlled trial will be conducted. Patients on mechanical ventilation for more than 2 days will be randomized to receive inhaled colistin twice daily for 3 days or inhaled placebo (0.9% Sodium Chloride). Primary outcome will be the occurrence of ventilator-associated pneumonia from randomization to day 28.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Children older than 1 month and younger than 14 years
- Patients on invasive mechanical ventilation for more than 48 hours
- Informed parental consent
- Suspected or confirmed VAP on the day of inclusion
- Indication for systemic colistin therapy before or at enrolment in the study
- Plan for extubation within the next 24H
- Known allergy to colistin
- No parental consent
- Colonization or infection with a germ resistant to colistin on admission
- Tracheostomy
- Appearance of allergic clinical manifestations in the days of colistin nebulization
- Appearance of undesirable clinical or biological manifestations presumed attributable to nebulization with colistin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description colistin group colistimethate sodium Colistin group: In the Nebulized Colistin (NC) group, 30 000 IU/kg of colistimethate sodium (equivalent to 0.96 mg/kg of colistin base), (maximum 750000 IU) will be nebulized daily, divided into two doses. The lyophilisate of colistin will be reconstituted as follows: 1 million of IU is reconstituted in 3 mL of sterile 0.9% saline. The adequate volume is then withdrawn and administered immediately to mechanically ventilated patients via a nebulizer until the nebulized solution container becomes empty. The nebulization is administered from day 3 of invasive mechanical ventilation, twice daily for 3 days or until extubation (whichever occurres first). \*12500 International Units of colistimethate sodium = 1 mg colistimethate sodium = 0.4 mg of colistin base. Control group 0.9% Saline Nebulization of 3 ml of 0.9% saline twice a day for 3 days from day 3 of invasive mechanical ventilation will be administered via a nebulizer until the nebulized solution container becomes empty.
- Primary Outcome Measures
Name Time Method Incidence of Ventilation Associated Pneumonia From randomization to 28 days post-randomization Primary outcome will be the incidence of a first episode of ventilation associated pneumonia from randomization to day 28. Incidence will be calculated as the ratio of the number of patients experiencing a first VAP episode divided by the number of randomized patients
- Secondary Outcome Measures
Name Time Method Incidence of Ventilation Associated Tracheobronchitis From randomization to 28 days post-randomization Incidence of first episode of ventilation associated tracheobronchitis (VAT) from randomization to day 28.
Incidence of a first episode of VAP and VAT in the subgroup of patients with tracheobronchial bacterial colonization at randomization From randomization to 28 days post-randomization This secondary outcome measures the incidence of the first episode of ventilator-associated pneumonia (VAP) and ventilator-associated tracheobronchitis (VAT) within the first 28 days post-randomization in patients who had tracheobronchial bacterial colonization at the time of randomization. The 28-day period is selected to capture early occurrences of these infections and to evaluate the effectiveness of preemptive colistin nebulization in this high-risk subgroup.
Number of days spent on mechanical ventilation from randomization to day 28 From randomization to 28 days post-randomization This secondary outcome measures the total number of days a patient remains on mechanical ventilation within the first 28 days following randomization. The 28-day period is chosen to assess the impact of preemptive colistin nebulization on reducing the duration of mechanical ventilation during the critical initial phase of ICU treatment.
Number of days without systemic antibiotics from randomization to day 28 From randomization to 28 days post-randomization This secondary outcome measures the number of days without systemic antibiotic use within the first 28 days after randomization. The 28-day period is chosen to assess the impact of preemptive colistin nebulization on reducing the requirement for systemic antibiotics during the initial critical period of ICU treatment
ICU stay From randomization to ICU discharge, up to 60 days Number of days spent in the ICU after randomization. This secondary outcome measures the length of stay in the ICU, defined as the number of days from randomization to ICU discharge. The time frame is chosen to comprehensively assess the duration of ICU treatment, which may be affected by the incidence of ventilator-associated pneumonia (VAP) and the impact of preemptive colistin nebulization on patient recovery
Incidence of antibiotic-resistant bacteria From randomization to ICU discharge This secondary outcome measures the incidence of antibiotic-resistant bacteria isolated from routine clinical and hygiene samples collected from the date of randomization until ICU discharge. The time frame is chosen to monitor the development and prevalence of antibiotic-resistant bacteria throughout the entire ICU stay, providing insights into the impact of preemptive colistin nebulization on bacterial resistance patterns.
ICU day-28 mortality 28 days from ICU admission This secondary outcome measures the mortality rate within 28 days of ICU admission. The time frame of 28 days is selected to assess early mortality outcomes related to ventilator-associated pneumonia and to evaluate the potential impact of preemptive colistin nebulization on patient survival during the initial critical period.